Medical fluids handling and administering apparatus



Oct. 31, 1961 E. J. POITRAS 3,006,341

MEDICAL FLUIDS HANDLING AND ADMINISTERING APPARATUS Filed March 29, 19545 Sheets-Sheet 1 E. J. POITRAS Oct. 31, 1961 MEDICAL FLUIDS HANDLING ANDADMINISTERING APPARATUS 5 Sheets-Sheet 2 Filed March 29, 1954 l'zweniorEda/(12 d cll'aifia cw,

I I M 1 WM my 332590 Oct. 31, 1961 E. J. POITRAS 3,006,341

MEDICAL FLUIDS HANDLING AND ADMINISTERING APPARATUS Filed March 29, 19545 Sheets-Sheet 3 laavezaoa": Edzvard JPQifJM, 6y g ff; MI /%rl(/MM M 7flitlys United States Patent 3,006,341 MEDICAL FLUIDS HANDLING ANDADMINISTERING APPARATUS Edward J. Poitras, 198 Highland St., Holliston,Mass. Filed Mar. 29, 1954, Ser. No. 419,496 9 Claims. (Cl. 128-214) Mypresent invention relates to medical equipment and techniques, and moreparticularly to an improved method and apparatus for handling medicalfluids. It aims to provide an integral, unitary, closed, sealed systemfor such handling and with minimum chance for the con-v tamination ofthe fluids. In one embodiment here concerned it aflects moreparticularly the sterile, anti-coagulant collecting, storing andinfusing of blood.

The invention will be better understood from the following descriptiontaken in conjunction with the accompanying drawing in which:

FIG. 1 is an assembly view of the embodiment of the invention adapted tohandling and administering blood;

FIG. 2 shows an alternative form of one of the features of FIG. 1;

FIG. 3 is a plan of another embodiment of the medical fluids handlingequipment; and

FIGS. 4 and 5 show the embodiment of FIG. 3 as fitted for shipping andstorage.

A primary objective in the design and construction of apparatus forhandling medical fluids is reducing and holding to a minimum thepossibility of contamination of the fluids. Ideally the apparatus shouldbe of unitary or one piece construction, thus providing an integralpassage sealing the fluids against any exposure to atmosphere orcontaminating influence throughout the handling and administering of thesame. In the case of blood, for example, a completely sealed apparatusand a sterile technique is required for the necessary preservation ofshed blood against coagulation and degradation. It has been establishedalso that medical fluids handling equipment should be non-toxic,non-reactive, and susceptible of sterilization under medicallyacceptable conditions. My present invention provides new and improvedmeans and methods which meet these requirements and specifications.

Generally considered, the apparatus of the invention comprises a unitaryhermetic-sealed fluid handling systern. It incorporates centrally aclosed collapsible container defining a storage means or reservoir forthe fluid. Integrally associated therewith are sterile sealed assembliesfor supplying and administering the fluids to and from the reservoir.Further, the unitary fluid container and conduits and associated fluidcontacting elements of the invention system are fashioned of a flexiblelight weight material which is non-reactive to the fluids, particularlyblood, and which provides a compact, inexpensive and durable apparatus.

In its embodiments adapted specially to the handling of blood, theapparatus of the invention comprises more particularly integrallyassociated means for the sterile collection, anti-coagulant storage, andfiltered infusion of the blood. Such means are predeterminedly andimportantly hemo-repellant, by which is meant that the surfaces whichthey present for contact with the blood are chemically inert ornon-reactive, and exert repulsive forces to fend off the formed elementsand proteins concerned in the blood-clotting mechanism.

In its every form, the invention system may be placed and preserved incompletely sterile condition, and eifectively seals the blood or othermedical fluid against contamination from any source.

Referring now more particularly to the drawing, one embodiment of theblood handling form is shown in FIG. 1, with the means for theanti-coagulant storage of the blood indicated generally at 10.Integrally associated therewith in the unitary donor-recipient set ofFIG. 1 are a collecting assembly indicated generally at A and afiltering and infusing assembly identified generally at B. In accordancewith the invention, in the manufacture of the central storage means 10and also the integrally associated donor-recipient assemblies A B, aflexible, lightweight material providing inert, impermeable, glossy andnon-toxic surfaces and chaarcterized also and importantly by the abovedefined quality of heme-repellence is employed. Other characteristicsdesired for and provided in the appaartus of the invention includetensile and flexural strength, or a general toughness, together withstability to sterilizing temperatures of at least C. and capacity forhermetic sealing by heat. I prefer to use materials selected from theelastomeric thermoplastic resins class and more particularly from thepolyvinyl chloride group as best exemplifying these qualities andcharacteristics.

The blood storing means 10 comprises a deformable, collapsiblecontanier, vessel, or bag formed from a tubular envelope or sleeve whichis closed and more particularly dielectrically heat-sealed or fused atits ends along the bands or margins 11, 12. The bag 10 is manufac turedfrom thin, manually manipulable stock in the tough flexible plasticmaterial above mentioned and with a suitable volume, which may be thataccommodating an adult donation together with the appropriate quantityof anti-coagulant. In one comemrcial embodiment, for example, the bag issized for a donation of 500 cc. collected into 75 cc. of acid citratedextrose. The described bag construction is seen to be one which iscompletely collapsible flatwise, and thus adapted to evacuation prior touse as desired for minimum liquid gas interface. And in use it providesa compact, lightweight and relatively indestructible blood storing meanswhich lends itself to quick and certain handling both in the hospitaland in the field.

Integrally associated with the bag 10 in my novel system is a collectingtube 13, one end of which is passed through the end wall or flattedclosure 11 before it is heat sealed, or fused together and about thesaid tube end. The said one or inner end of the tube 13 may be stopperedor closed for a reason hereinafter apparent by a slightly oversizedhemo-repellent bead 14, lodged in the same in the region of the closure11. The free end of the tube 13 is seized over a phlebotomy needle 15 ofa type adapted specially for use with the invention apparatus and shownto comprise handling and manip ulating means including a centralgripping portion 150, conical hubs 15b, 15c extending oppositelythereof; and a blood letting tube or cannula 15d extendinglongitudinally from the hub 150. The cannula may project within themanipulating portion 15a,b,c, for the full length of the needle and maybe coated interiorly with a hemo-repellent film or liner in accordancewith known practice. Surrounding the said cannula 15d and tightly drawnover the proximate hub 150 is a sealing sheath 16, the outer end ofwhich has been flatted and fused about the tip of the cannula, therebyeffecting desired sterile, hermetic sealing of the needle tip and alsoof the entire system in unitary association therewith.

Integrally connected also to the central blood bag 10 is the outlet orinfusing assembly indicated generally at B and shown more particularlyto comprise outlet tube 17, which is passed through and similarly fusedto the bag wall at the end seal 12. This integral outlet tube 17 isprovided with a novel closure or seal located within the bag 10 butmanipulated, disengaged, or removed from without the bag, and withoutrequiring the opening of the same or the destroying or disturbing of thehermetic seal obtaining throughout the system. Such novel outlet seal isshown as a fragment of the bag material formed as a tear tab 17asupported across and detachably fused to the tube end projecting withinthe bag.

Further in accordance with the invention, means are providedintermediate the infusing or recipient assembly B for filtering anddetecting or observing the flow of the blood. Referring still to FIG. 1,such means are seen as the drip chamber and filter assembly indicatedgenerally at 18. My novel drip chamber and filter comprises a sleeve orlarger tube flatted and fused at one end margin 19 and at anintermediate lateral band 20. The end closure 19 is sealed about theoutlet tube 17, the free end of which is seen to project within thesleeve 18. A nylon mesh screen 21 of appropriate gauge is received inthe chamber defined between the end and the intermediate seals 19, 20.The lower or outermost portion of this assembly or sleeve 18 is formedas a relatively rigid chamber by collapsing and fusing the lower sleeveend or margin 22 in a plane at right angles to that of the upper andintermediate lateral margins or bands 19, 20. Fluid passage between thefilter and drip chambers is afforded by a tube 23 fused in and extendingthrough the intermediate seal 20.

Outward of the described filter drip chamber in the recipient assemblyis an infusing tube 24 having one end integrally received within thedrip chamber and seized at the other to a suitable infusing needle 25,which latter has drawn over it a sealing sheath 26 similarly as with thecollecting tube 13. The flow of the blood through the infusing orrecipient tube 24 may be regulated by any suitable means, such as thecontrol clamp or clip 27.

The collapsible blood storing and preserving means central to thedescribed blood handling form may be provided with additional oralternative means for the outlet or discharge of the blood or bloodfraction. Such means may comprise for example a relatively short tube28, entering and fused to the bag in the same manner as and adjacent theoutlet tube 17, and closed off in the region of said bag by apuncturable diaphragm 28a. The exposed, outwardly projecting portion ofthe tube 28 is encased with a removable sealing sheath or pouch 29 suchas originally shown and described in the co-pending application of DavidBellamy, S.N. 412,549, filed February 25, 1954, now Patent No. 2,894,510and comprising duplicate strips of the bag material received and fusedbetween the opposed walls defining the lower bag margin 12 and fusedtogether also about said projecting tube portion so as to define asterile sealed region or pocket 29a.

It may here be noted that for the diaphragm closures 17a, 28a there maybe substituted a manually displaceable, hemo-repellent bead such asalready described for the collecting assembly. In FIG. 2 the bloodstoring bag 30 has an outlet tube 32, into which is seized an oversizedhead 33, positionedoutwardly of the bag margin 31, and additionallyretained by an elastic ring or clamping band 34 proportioned normally tocompress the tube 32 and to contract the same about the head 33. Theband 34 incorporates a manipulating tab 34a whereby the same isconveniently withdrawn from the indicated clamping position and the beadfreed for manual ejection from the tube 32 into the blood pack 30.

The integral blood handling or donor recipient set of FIG. 1 is preparedfor use by evacuating it and charging the bag and donor tube 13 with theindicated quantity of anti-coagulant solution, commonly acid citratedextrose solution A, U.S.P. The apparatus is fully assembled or sealedand then sterilized according to medically accepted practice. Finally,it is folded or rolled into a compact lightweight and relativelyindestructible package or kit.

In use and for collection of the blood, the bag is hung inverted, sothat the blood will flow into the ACD solution. A loose knot is formedin the donor tube 13, the

sheath 16 is removed, and the needle applied for phlebotomy at a siteprepared in known manner. Influx of air into the system and also efiluxof the ACD solution is prevented by the bead 14, which is manuallyworked or milked out of the tube and into the bag 10 to permit the bloodflow. The blood bag having been filled by gravity, the knot in thecollecting tube 13 is pulled tight before the needle 15 is removed,thereby sealing the bag and contents against contamination. For storageof the blood, the donor tube is conveniently dielectrically sealed olfnear the bag. The bag is then suspended or hung up in any convenientmanner for storage, refrigerated at 4 C. i 1. It will be appreciatedthat by the method and with the apparatus just described, safe storageof whole blood is had for the maximum period, or for up to 25 days.

It should here be noted also that one may alternatively employ for thesterile anti-coagulant collection of the blood a blood pack equippedwith an ion exchange column, such as shown and described in theco-pending application of Carl W. Walter, S.N. 174,891, filed July 20,1950, now Patent No. 2,702,034, dated February 15, 1955.

In infusing practice, the red cells and plasma are first thoroughlymixed. The outlet closure 17a is then removed by appropriatemanipulation of the bag 10 and the filter chamber squeezed and thenreleased to establish a halfway blood level therein. The infusion needlesheath 26 may then be removed and the blood flowed to thoroughly expelthe air from the recipient tube 24. When the venipuncture is made theblood is flowed by gravity, being filtered as at the screen 21, observedas at the drip chamber 219, 23, and regulated as by the control clip 27.

When the blood is outdated, or for extraction of plasma from the bag 10,the outlet tube 28 may be employed. In this the opposing strips of thetab 29 are pulled apart to expose the end of the tube and a couplerneedle is inserted and seized in the same with its tip piercing thediaphragm 28a, all as shown and described in the abovementionedco-pending application of Bellamy. It will be understood that wheredesired such tab-sealed tube 28 may also be employed as an inlet. Thesame or additional blood or other fluid solutions might be desired to beintroduced into the pack during or after emptying or administering thefluid originally filled. The present system permits, of course, theadministering of more than one solution without removing the recipientneedle from the patient. The filling of the pack through the tube 28,identical with that just described requires but the pulling apart of theopposing strips of the tab 29 to expose the ends of hte tube and theinsertion of a coupler needle so as to' seize in the tube and pierce thediaphragm 28a.

Another form of the compact, lightweight, sterile sealed medical fluidshandling equipment of the invention, and more particularly a unitaryparenteral solution pack and intravenous set is illustrated in FIGS. 3,4 and 5. In the embodiment therein shown the pack comprises a sleevedesignated generally at 40 and formed as a collapsible bag by sealingits ends 41, 42 similarly as with the blood pack 10 already described.The opposing walls of the bag 40 are seen to be fused together at oneend 41 about an inlet tube 43 and also about an outlet tube 44 formingpart of a unitary infusing assembly. Said assembly further comprises adrip chamber 45 integrally coupled to the tube 44 and defined like thedrip chamber of FIG. 1 by a relatively short length of larger tubingflatted and sealed at its ends in longitudinal planes which arepredeterminedly normal, one to the other. Integrally coupled to theouter end of said chamber is an infusing tube 46, mounting a needle 47,the latter encased in a sealing sheath 48.

The parenteral solution pack and intravenous set of FIG. 3, is preparedfor use in the same manner as the blood pack of FIG. 1, namely, by firstevacuating and filling it with the desired solution and then sterilizingit in ac cordance with known practice. The bag 40 is filled through theinlet 43, which is shown as sealed off as at 43a after filling. Withrespect to the embodiments of FIGS. 1 and 3 it will be understood thatthe elements and appendages of the one may be employed interchangeablywith those of the other, without departing from the invention. Forexample, and as will be obvious, the FIG. 3 form may be provided withfluid inlet-outlet means additional to the inlet and outlet 43, 44 thereshown, as for example the upper end inlet such as illustrated at A, FIG.1.

My present invention further comprises means for storing and preservingmy novel parenteral pack without solution vapor loss and without kinkingof the infusing tube prior to use. As illustrated in FIGS. 4 and 5, suchmeans.

comprise a can or container 50 of desired proportions and in which thebag 40 is deposited, upper end 42 first. In accordance with theinvention the container 50 provides in combination with the bag 40 ahumid atmosphere or vapor barrier preventing the undesired drying out ofthe pack in storage. A protective spacer or cup 51 is next inserted inthe can. The cup 51 is seen to have a bottom opening 51a such that itmay he slipped down over the infusing assembly to engage, and to be of aheight to confine the bag 40 in the position shown in FIG. 5. Anincomplete or parti-cylindrical ring or form 52 having a radius slightlysmaller than the cup 51 is next inserted in the can and positioned withits vertical wall opening opposite the drip chamber 45, FIG. 4. Kinkingof the infusing tube 46 is prevented in accordance with the invention byconfining it to the periphery of the can 50 and more particularly bycoiling it to lay flat about and between the concentric form 52 and cup51, FIGS. 4 and 5. The storage assembly of the parenteral pack iscompleted by seating the needle 47 in the complementary recesses 52a inthe upper rim of the holder 52 and then applying the can cover 50a, FIG.5. The parenteral pack is thus ordered for shipping and storage isdesired vapor sealed and confined conditions and in uniquely compactlightweight assembly.

In use my novel parenteral pack is manipulated similarly as the bloodpack according to a simple, sure and thorough technique. The apparatusis first arranged with the pack 40 supported for gravity or pressureflow to the patient or recipient. The sheath 48 is then removed andvenipuncture eifected at a prepared site. Flow of the parenteral fluidis initiated by removing the infusing column closure, which may comprisefor example a tear tab 44a sealing the bag outlet 44. The flow of theparenteral solution will be observed at the chamber 45, and mayadditionally be controlled in known manner.

From the foregoing it will be appreciated that my present inventionprovides a simple sure method and compact lightweight and durableapparatus for the handling and administering of medical fluids. Further,the collection, storage and infusion of blood has been shown to beconducted under the invention in a closed, heme-repellent, sterilesealed system, wherein air-blood interface, platelet aggregation, andcontamination *of the blood is eliminated or retarded throughout itspassage from donor to storage reservoir to recipient. The inventionapparatus will be understood additionally to comprise apparatus for thestorage and transport of the medical fluid handling equipment in desiredsterile-preserving and substantially indestructible condition.

It will be understood that my invention either as to means or method isnot limited to the exemplary embodiments or steps here illustrated ordescribed, and I set forth its scope in the following claims:

I claim:

1. Apparatus for handling and administering medical fluids, comprising acollapsible bag, a fluid outlet on the bag, a fluid administering setpermanently sealingly connected at said outlet and incorporating thereina drip chamber, means removably sealing the administration set at theend remote from the bag, and a closure element positioned within theapparatus at said outlet and maintaining said bag closed when saidsealing means is removed to open said administration set, said closureelement manipulable from without and through the walls of the apparatusto remove it from its outlet closing position and thereby to open saidbag to said administration set.

2. The apparatus of claim 1 wherein said closure element is an oversizedbead lodged in the outlet and which is removed by manually working itout into the bag.

3. Apparatus for the collection, storage and infusion of bloodcomprising storing means including a collapsible container; collectingmeans including a tube adapted at one end for connection to a bloodsupply and at the other end sealingly aifixed and admitting into thecontainer; infusing means including a tube sealingly alfixed to andcommunicating with the container and means integrally associatedtherewith for dripordering, observing and regulating the flow of theblood; means removably sealing the outer ends of said collecting andinfusing means and whereby said storing container and collecting andinfusing means are integrally connected in a closed, sterile sealedsystem presenting a continuous donor-to-recipient passage for the blood;and closure means positioned within said system and for sealing saidcollecting and infusing tubes in the region of said container, saidclosure means manip ulable from without and through the walls of saidsystem for removal from the sealing position and to open said collectingand infusing tubes to said container.

4. Apparatus for the collection, storage and infusion of bloodcomprising storing means including a collapsible container; collectingmeans including a tube adapted at one end for connection to a bloodsupply and at the other end sealingly aflixed and admitting into thecontainer; infusing means including a tube sealingly affixed to andcommunicating with the container and means integrally associatedtherewith for drip-ordering, observing and regulating the flow of theblood; means removably sealing the outer ends of said collecting andinfusing means and whereby said storing container and collecting andinfusing tubes are integrally connected in a closed, sterile sealedsystem presenting a continuous donor-to-recipient passage for the blood;and closure means positioned within said system and for sealing saidcollecting and infusing tubes in the region of said container, saidclosure means manipulable from without and through the walls of saidsystem for removal from the sealing position and to open said collectingand infusing tubes to said container, and at least one said closuremeans comprising an over-sized hemorepellent bead lodged in theassociated tube.

5. Apparatus for the collection, storage and infusing of bloodcomprising storing means including a collapsible container; collectingmeans including a tube adapted at one end for connection to a bloodsupply and at the other end sealingly affixed and admitting into thecontainer; in fusing means including a tube sealingly affixed to andcommunicating with the container and means integrally associatedtherewith for drip-ordering, observing and regulating the flow of theblood; means removably sealing the outer ends of said collecting andinfusing means and whereby said storing container and collecting andinfusing tubes are integrally connected in a closed, sterile sealedsystem presenting a continuous donor-to-recipient passage for the blood;and closure means positioned within said system and for sealing saidcollecting and infusing tubes in the region of said container, saidclosure means manipulable from without and through the walls of saidsystem for removal from the sealing position and to open said collectingand infusing tubes to said container, and at least one said closuremeans comprising a hemorepellent bead lodged in the associated tube, aclamping ring expanded over said bead and tube, and a manipulating tabon said ring.

6. Apparatus for the collection, storage and infusion of bloodcomprising a collapsible bag evacuated and partially filled with ananticoagulant solution, an inlet and a plurality of outet tubes havingintegral connection to and defining passages opening into said bag,means re movably sealing the outer ends of said inlet and outlet tubes,and means positioned within the apparatus and removably closing saidinlet and outlet tube passages in the region of said bag, said closingmeans being engageable to open said passages without disturbing theintegral connection of said tubes to said bag.

7. Apparatus for the collection, storage and infusion of bloodcomprising a collapsible bag evacuated and partially filled with ananticoagulant solution, an inlet and a plurality of outlet tubes havingintegral connection to and defining passages opening into said bag,means removably sealing the outer ends of said inlet and outlet tubes,and means positioned within the apparatus and removably closing saidinlet and outlet tube passages in the region of said bag, said closingmeans being engageable to open said passages Without disturbing theintegral connection or" said tubes to said bag, the means closing theinlet tube being an oversized hemorepellent bead lodged in the tube andwhich may be manually worked out of the tube and into the bag, and themeans closing one said outlet tube being a puncturable diaphragm.

8. Apparatus for the collection, storage and infusion of bloodcomprising a collapsible bag evacuated and partially filled with ananticoagulant solution, an inlet and a plurality of outlet tubes havingintegral connection to and defining passages opening into said bag,means removably sealing the outer ends of said inlet and outlet tubes,and means positioned within the apparatus and removably closing saidinlet and outlet tube passages in the region of said bag, said closingmeans being engageable to open said passagm without disturbing theintegral connection of said tubes to said bag, the means closing theinlet tube being an oversized hemorepellent bead lodged in the tube andwhich may be manually worked out of the tube and into the bag, and themeans closing one said outlet tube being a tear tab detachably sealedacross its end and manipulable for removal from without the apparatus.

e 9. Apparatus for collecting and storing blood comprising a collapsiblestorage bag, a flexible collecting tube permanently sealingly joined andcommunicating to said bag, a needle at the free end of the collectingtube, a sealing sheath removably installed on said needle, fluiddelivery means permanently sealingly joined and communieating to saidbag, means positioned within the apparatus and removably closing saidcollecting tube and said delivery means in the region of said bag, andmeans closing said delivery means outside said bag, said outside closingmeans having projecting portions adapted to be grasped between thefingers and pulled apart to open said delivery means.

References Cited in the file of this patent UNITED STATES PATENTS714,544 Wertz Nov. 25, 1902 920,225 Van Denburgh et al May 4, 19092,452,644 Fields Nov. 2, 1948 2,625,264 Edwards Jan. 13, 1953 2,663,298Rose Dec. 22, 1953 2,702,034 Walter Feb. 15, 1955 2,848,995 Ryan Aug.26, 1958 2,894,510 Bellamy July 14, 1959 2,949,712 Bieberdorf et a1 Aug.23, 1960 FOREIGN PATENTS 383,204 Germany Oct. 11, 1923 OTHER REFERENCESBaxter: Intravenous Solutions, Transfusion Equipment, Plasma and Serum,and Preparation Equipment, Apr. 27, 1942, 7 pages, page 3 relied upon.(Copy Div. 55, 128-214.)

Walter et al.: A Closed Gravity Technique for the Preservation of WholeBlood in Acid Solution Utilizing Plastic Equipment, Surgery, Gynecology,and Obstetrics, volume 94, No. 6, June 1952, pages 687692, pages 687-692 relied upon. (Copy in Scientific Library.)

